Prevention of exercise-induced bronchospasm in patients 12 years of age and older.

AMOXICILLIN

SMITHKLINE BEECHAM

50-542

06-Oct-97

27-Feb-98

SE1

4.7

For use in combination with lansoprazole (with or without clarithromycin) in patients with duodenal ulcer (defined as an active ulcer or history of an ulcer within one year) to eradicate Helicobacter pylori and reduce the risk of duodenal ulcer recurrence.

ANAGRELIDE HYDROCHLORIDE

ROBERTS LABS

20-333

02-Jan-98

16-Dec-98

SE1

11.4

Treatment of patients with thrombocythemia, secondary to myeloproliferative disorders, to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms including thrombo-hemorrhagic events.

ANASTROZOLE

ZENECA PHARMS

20-541

10-Feb-97

06-Feb-98

SLR

11.9

Treatment of advanced breast cancer in postmenopausal women who have progressed following tamoxifen therapy.

APROTININ

BAYER

20-304

06-Nov-96

28-Aug-98

SE1

21.7

Prophylactic use to reduce perioperative blood loss and the need for blood transfusion in patients undergoing cardiopulmonary bypass in the course of coronary artery bypass graft surgery.

Revises the dosage directions for the prevention of meal-induced heartburn from "…take one tablet 30 minutes before eating…" to "…take one tablet just before or anytime up to 30 minutes before eating…".

CIPROFLOXACIN

BAYER

19-847

22-Dec-95

03-Apr-98

SE5

27.4

Provides for the addition of information to the Pediatric Use subsection of the labeling pertaining to the use in cystic fibrosis patients.

CIPROFLOXACIN

BAYER

19-857

22-Dec-95

03-Apr-98

SE5

27.4

Provides for the addition of information to the Pediatric Use subsection of the labeling pertaining to the use in cystic fibrosis patients.

CIPROFLOXACIN

BAYER

19-858

27-Dec-95

03-Apr-98

SE5

27.2

Provides for the addition of information to the Pediatric Use subsection of the labeling pertaining to the use in cystic fibrosis patients.

Provides for the addition of information to the Pediatric Use subsection of the labeling pertaining to the use in cystic fibrosis patients.

CISATRACURIUM BESYLATE

GLAXO WELLCOME

20-551

24-Oct-97

15-Oct-98

SE8

11.7

Adjunct to general anesthesia, to facilitate tracheal intubation, and provide skeletal muscle relaxation during surgery or mechanical ventilation in the ICU.

CISATRACURIUM BESYLATE

GLAXO WELLCOME

20-551

19-Jun-97

19-Jun-98

SLR

12.0

Adjunct to general anesthesia, to facilitate tracheal intubation, and provide skeletal muscle relaxation during surgery or mechanical ventilation in the ICU.

CLARITHROMYCIN

ABBOTT LABS

50-662

12-Nov-97

16-Sep-98

SE1

10.1

For the use in combination with omeprazole and amoxicillin, as triple therapy for the treatment of patients with Helicobacter pylori infection and duodenal ulcer disease (active or one-year history of duodenal ulcer) to eradicate Helicobacter pylori.

CLINDAMYCIN PHOSPHATE

PHARMACIA AND UPJOHN

50-680

08-May-95

02-Mar-98

SE2

33.8

Provides for a 3-day dosing regimen of 2% clindamycin phosphate vaginal cream in the treatment of bacterial vaginosis.

DESMOPRESSIN ACETATE

RHONE POULENC RORER

19-955

26-Mar-97

25-Mar-98

SE1

12.0

Primary nocturnal enuresis.

DEXTROSE

ABBOTT LABS

19-445

25-Nov-97

23-Nov-98

SE5

11.9

Provides for a new Sub-population - Neonates and older infants for approved use as a minimal source of carbohydrates and calories in this population.

DEXTROSE

ABBOTT LABS

19-445

25-Nov-97

23-Nov-98

SE1

11.9

Provides for a new indication in the treatment acute symptomatic episodes of hypoglycemia in the neonate and older infant to restore depressed blood glucose levels and control symptoms.

DICLOFENAC SODIUM

CIBA VISION CORP

20-037

30-Sep-96

25-Feb-98

SE1

16.9

For the temporary relief of pain and photophobia in patients undergoing corneal refractive surgery.

DILTIAZEM HYDROCHLORIDE

BIOVAIL LABS

20-401

30-Jan-97

30-Jan-98

SE1

12.0

Treatment of chronic stable angina.

DOCETAXEL

RHONE POULENC RORER

20-449

22-Dec-97

22-Jun-98

SE7

6.0

Treatment in patients with locally advanced or metastatic breast carcinoma in whom previous therapy has failed.

ENOXAPARIN SODIUM

RHONE POULENC RORER

20-164

01-Apr-96

30-Jan-98

SE1

22.0

Prevention (during and following hospitalization) of deep vein thrombosis, which may lead to pulmonary embolism, in patients undergoing hip replacement surgery.

ENOXAPARIN SODIUM

RHONE POULENC RORER

20-164

18-Mar-97

27-Mar-98

SE1

12.3

Prevention of ischemic complications of unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin.

ENOXAPARIN SODIUM

RHONE POULENC RORER

20-164

28-Feb-97

31-Dec-98

SE1

22.1

Inpatient treatment of acute deep vein thrombosis with and without pulmonary embolism, when administered in conjunction with warfarin sodium; and for the outpatient treatment of acute deep vein thrombosis without pulmonary embolism when administered in conjunction with warfarin sodium.

EPROSARTAN MESYLATE

SKB PHARMS

20-738

26-Jan-98

28-Oct-98

SE2

9.0

Once daily dosing regimen for the treatment of essential hypertension.

ESTROGENS, CONJUGATED

WYETH AYERST LABS

04-782

22-Feb-94

08-Sep-98

SE2

54.5

Prevention of osteoporosis.

ESTROGENS/ CONJUGATED MEDROXYPRO-GESTERONE ACETATE

WYETH AYERST LABS

20-527

09-Jan-97

09-Jan-98

SE2

12.0

Treatment of moderate to severe vasomotor symptoms associated with the menopause; treatment of vulvar and vaginal atrophy; prevention of osteoporosis.

Relief of heartburn associated with acid indigestion and sour stomach and for prevention of heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages.

FINASTERIDE

MERCK

20-180

19-May-97

20-Mar-98

SE5

10.0

Treatment of benign prostatic hyperplasia (BPH) in men with an enlarged prostate to improve symptoms, reduce the risk of acute urinary retention and reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy.

FINASTERIDE

MERCK

20-180

22-Sep-97

20-Mar-98

SE1

5.9

Treatment of benign prostatic hyperplasia (BPH) in men with an enlarged prostate to improve symptoms, reduce the risk of acute urinary retention and reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy..

FLUTICASONE PROPIONATE

GLAXO WELLCOME

20-121

18-Dec-97

11-Dec-98

SE1

11.8

Treatment of nasal symptoms of perennial nonallergic rhinitis in adults and pediatric patients 4 years and older.

GABAPENTIN

PARKE DAVIS PHARMS

20-235

16-Sep-96

29-Sep-98

SE2

24.4

Adjunctive therapy in the treatment of partial seizures with and without secondary generalization in adults with epilepsy.

GEMCITABINE HYDROCHLORIDE

LILLY

20-509

29-Aug-97

25-Aug-98

SE1

11.9

In combination with cisplatin for the first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB) or metastatic (Stage IV) non-small cell lung cancer.

GLIPIZIDE

PFIZER

20-329

03-Jul-97

04-Feb-98

SE1

7.1

Provides for combination therapy with metformin when satisfactory lowering of blood glucose is not achieved with Gulcotrol XL alone.

GOSERELIN ACETATE

ZENECA (UK)

20-578

12-Aug-97

27-Jul-98

SE1

11.5

Provides for the use in combination with flutamide for the management of locally confined Stage T2b-T4 (Stage B2-C) carcinoma of the prostate.

GOSERELIN ACETATE

ZENECA PHARMS

19-726

09-Apr-97

09-Apr-98

SE1

12.0

Palliative treatment of advanced carcinoma of the prostate; management of endometriosis.

GOSERELIN ACETATE

ZENECA PHARMS

19-726

12-Aug-97

27-Jul-98

SE1

11.5

In combination with flutamide for the management of locally confined Stage T2b-T4 (Stage B2-C) carcinoma of the prostate.

HYDROXYUREA

BRISTOL MYERS SQUIBB

16-295

12-May-97

25-Feb-98

SE1

9.5

To reduce the frequency of painful crises and to reduce the need for blood transfusions in adult patients with sickle cell anemia with recurrent moderate to severe painful crises (generally at least 3 during the preceding 12 months).

Revision to the Directions section of the labeling to change the time to take the drug prior to a meal to prevent meal-induced heartburn symptoms from "…one-half to one hour before eating…" to "…right before eating or up to 60 minutes before consuming...".

OMEPRAZOLE

ASTRA MERCK

20-916

30-Sep-97

29-Jun-98

N

8.9

Concomitant use with amoxicillin and clarithromycin for the eradication of Helicobacter pylori in patients with duodenal ulcer disease.

OMEPRAZOLE

ASTRA MERCK

19-810

15-Apr-98

30-Jun-98

SE8

2.5

Concomitant use with amoxicillin and clarithromycin for the eradication of Helicobacter pylori in patients with duodenal ulcer disease.

PACLITAXEL

BRISTOL MYERS SQUIBB

20-262

09-Oct-97

09-Apr-98

SE1

6.0

First-line therapy for the treatment of advanced carcinoma of the ovary in combination with cisplatin.

PACLITAXEL

BRISTOL MYERS SQUIBB

20-262

30-Jun-97

30-Jun-98

SE1

12.0

In combination with cisplatin for the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy.

PAMIDRONATE DISODIUM

NOVARTIS PHARMS

20-927

22-Sep-97

22-Sep-98

N

12.0

In conjunction with standard antineoplastic therapy for the treatment of osteolytic bone metastases of breast cancer.

PENTAZOCINE LACTATE

ABBOTT LABS

16-194

02-Jan-98

22-Oct-98

SE8

9.6

Relief of moderate to severe pain for pediatric use.

PILOCARPINE HYDROCHLORIDE

MGI

20-237

12-Feb-97

11-Feb-98

SE1

12.0

Treatment of symptoms of dry mounth in patients with Sjogren's syndrome.

PORFIMER SODIUM

QLT

20-451

10-Feb-97

09-Jan-98

SE1

10.9

Photodynamic therapy for treatment of microinvasive endobronchial non-small cell lung cancer in patients for whom surgery and radiotherapy are not indicated.

PORFIMER SODIUM

QLT

20-451

10-Feb-97

22-Dec-98

SE1

22.4

Photodynamic therapy for reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial non-small cell lung cancer.

PRAVASTATIN SODIUM

BRISTOL MYERS SQUIBB

19-898

02-Sep-97

11-Mar-98

SE1

6.2

Reduction of triglycerides as a new indication.

PRAVASTATIN SODIUM

BRISTOL MYERS SQUIBB

19-898

31-Mar-97

27-Mar-98

SE1

11.9

For use in patients with previous myocardial infarction(MI) and normal cholesterol levels, to reduce risk of recurrent MI, myocardial revascularization, and cerebrovascular disease events.

PREDNISOLONE SODIUM PHOSPHATE

MEDEVA PHARMS

19-157

07-Apr-97

17-Dec-98

SE5

20.4

For pediatric use.

RALOXIFENE HYDROCHLORIDE

LILLY

20-815

27-Jul-98

24-Nov-98

SE8

3.9

Prevention of postmenopausal osteoporosis.

RANITIDINE BISMUTH CITRATE

GLAXO WELLCOME

20-559

01-Apr-97

23-Mar-98

SE2

11.7

Allows for a reduction in the dosing frequency of clarithromycin when used for the approved indication. Tritec in combination with clarithromycin is indicated for the treatment of patients with an active duodenal ulcer associated with Helicobacter pylori infection.

RANITIDINE HYDROCHLORIDE

GLAXO WELLCOME

20-520

06-Nov-96

08-Jun-98

SE1

19.0

Prevention of meal-induced heartburn when taken 30 to 60 minutes prior to a provocative meal.

SALMETEROL XINAFOATE

GLAXO WELLCOME

20-236

27-Mar-97

05-Feb-98

SE1

10.4

Long-term, twice-daily (morning and evening) administration in the maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.

SALMETEROL XINAFOATE

GLAXO WELLCOME

20-692

26-Sep-97

25-Sep-98

SE1

12.0

Treatment of exercise-induced bronchospasm in adults and children 4 years of age and older with reversible obstructive airway disease.

SALMETEROL XINAFOATE

GLAXO WELLCOME

20-692

26-Sep-97

25-Sep-98

SE5

12.0

Maintenance treatment of asthma and prevention of bronchospasm in adults and children 4 years of age and older.